Vanderbilt receives $7 million grant to study sedatives for critically ill patients

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Vanderbilt University Medical Center has received a $7 million, five-year funding award from PCORI (Patient-Centered Outcomes Research Institute) to compare two sedatives used to place breathing tubes in the emergency department (ED) or intensive care unit (ICU).

To provide support with a breathing machine, doctors must place a breathing tube into a patient's mouth and throat, and they are given a medication to make them sleep during this procedure. The two medications doctors most often give are ketamine and etomidate.

Millions of critically ill adults require placement of a breathing tube each year (tracheal intubation) in the ED or ICU. Of these, up to 30% die from their critical illness and up to one-third of survivors develop post-traumatic stress disorder (PTSD).

The Randomized trial of Sedative choice for Intubation (RSI) study will compare the effectiveness of ketamine versus etomidate during tracheal intubation of 2,364 critically ill adults at five centers (Vanderbilt, Hennepin, University of Alabama Birmingham, University of Colorado, and Wake Forest). Researchers will meet with patients in the hospital, then call patients at three and 12 months afterward.

"Even though these two medications have been around for decades, we still don't know which one is best for patients," said Matthew Semler, MD, MSc, assistant professor of Medicine in the Division of Allergy, Pulmonary and Critical Care Medicine and co-principal investigator of the study along with Jin Han, MD, MSc. "Knowing which of the two medications helps patients survive or prevents symptoms of PTSD could save lives and improve mental health for tens of thousands of seriously ill patients every year," Semler said.

Preliminary evidence suggests that the sedative used to relax the patient in preparation for tracheal intubation may affect the risk of death or PTSD."

Jin Han, MD, MSc

"Although millions of patients receive ketamine and etomidate each year, it is unknown which is best for the prevention of death or PTSD, which can last for months or years and impair survivors' ability to work, perform everyday tasks and have healthy relationships," he said.

The RSI trial will compare the effectiveness of the two medications with regard to mortality at one month among critically ill adults undergoing emergency tracheal intubation, compare the effectiveness of the two medications with regard to PTSD symptoms at 12 months and use analyses of heterogeneity of treatment effect to predict the effect of ketamine vs. etomidate on death and PTSD symptoms for individual patients.

The study's main outcome is the number of patients who are alive at one month. The secondary outcome will be patients' symptoms of PTSD at 12 months. Members of the research group will ask patients about their PTSD symptoms over the phone. They will also ask questions about how patients are thinking and feeling.

The study will be led by a team of five patients who have experienced serious illness, five doctors who care for patients with serious illness, and researchers from five hospitals with experience in serious illness, mental health, and involving patients and community members in research.

An independent group of patients and community members from the five cities will help oversee and direct the study. Every four months, additional patients and clinicians with diverse backgrounds will share their experiences, answer questions, and advise the study's design and conduct. Patient and clinician advocacy organizations will help design and shape the study.

VUMC's funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

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